Key Responsibilities
- Develop CMC regulatory strategy aligned with product development pipeline and clinical pathways
- Identify and interpret applicable regulations, ICH guidelines, and agency expectations for CMC compliance
- Author the CMC sections of regulatory filing and partner with Regulatory Affairs to ensure they are complete on time
- Manage manufacturing-related responses and regulatory correspondence
- Ensure CDMO manufacturing data, site information, and quality documentation are organized for regulatory submissions
- Provide technical guidance to CDMO on process development, analytical method development, formulation optimization, manufacturing, etc. to ensure CMC compliance with all regulatory requirements
- Coordinate with Quality team on batch testing, release criteria, and manufacturing data review
- Support supply chain management including shipment of non-clinical and clinical materials from CDMO
- Collaborate with internal functions on regulatory strategy, program timelines, manufacturing milestones, and CMC deliverables.
- Ensure CMC activities align with clinical development, regulatory submissions, and commercial launch timelines
- Work with external CMC consultants and support the development of commercial CMC strategy aligned with regulatory pathway
CMC Regulatory
CDMO Management
Strategic Collaborations
Basic Qualifications
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
- 10+ years of biopharmaceutical CMC development or regulatory affair experience
- Experience in process development, analytical methods, or formulation of protein therapeutics
- Deep regulatory knowledge and experience with FDA/EMA submissions
Preferred Qualifications
- Cross functional experience leading or coordinating CMC development in a biotech or pharmaceutical company
- Experience in managing CMC transitions from development to commercial manufacturing and supporting BLA filing
- Strong technical writing, investigative, and risk assessment skills.
- Ability to work independently and manage multiple vendor relationships with minimal direct supervision
About Attovia
Attovia™ is a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need. Our product candidates are internally discovered using our proprietary ATTOBODY™ platform, an evolution-driven, high-throughput biologics platform that enables the rapid discovery and creation of diverse biparatopic complex biologics. Our pipeline spans chronic pruritic diseases, inflammatory skin diseases, inflammatory bowel disease, and other immune-mediated conditions.
Our culture is centered around five core pillars:
• Integrity
• Learning & Growth
• Drive for Excellence
• Innovation
• Teamwork & Collaboration
We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.
Attovia is located in San Carlos, CA.
Attovia is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Learn more about Attovia: www.attovia.com
Notice to Employment Agencies
The Attovia talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the Human Resources department. Attovia shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.
Skills Required
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field
- 10+ years of biopharmaceutical CMC development or regulatory affairs experience
- Experience in process development, analytical methods, or formulation of protein therapeutics
- Deep regulatory knowledge and experience with FDA and EMA submissions
- Cross-functional experience leading or coordinating CMC development in a biotechnology or pharmaceutical company
- Experience managing CMC transitions from development to commercial manufacturing and supporting BLA filing
- Strong technical writing, investigative, and risk assessment skills
- Ability to work independently and manage multiple vendor relationships with minimal direct supervision
What We Do
Attovia is creating a pipeline of biotherapeutics for the treatment of immune-mediated diseases. We leverage ATTOBODY™, our proprietary biologics platform, to generate potentially first-in-class and best-in-class multi-specifics. ATTOBODIES utilize spatial positioning technology to achieve biparatopic target engagement. The biparatopic binding mode of ATTOBODIES results in ultra-high affinity, which translates to best-in-class potency in biologic activity. ATTOBODIES offer unconstrained engineering, making them an ideal modality for the development of multi-specific biologics, with tunable half-life translating to the potential for quarterly or less frequent dosing in patients. The high-throughput, evolution-based ATTOBODY discovery platform delivers a high degree of diversity at industry-leading speed, accelerating and de-risking therapeutics development, offering the potential to become the next-generation modality of choice. Learn more at www.attovia.com.
